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Concern over Gardasil mass vaccination campaign

Public health doctors and vaccine experts have expressed "increasing concerns" regarding the promotion of Merck & Co's cervical cancer vaccine, Gardasil

A report in the UK campaining newspaper, The Guardian, has revealed that public health doctors and vaccine experts have expressed "increasing concerns" regarding the promotion of Merck & Co's cervical cancer vaccine, Gardasil.

The government's advisory joint committee on vaccination and immunisation, which is considering whether to recommend the mass vaccination for all girls of 10 or 12, says it is under pressure and recently took the decision not to publish minutes of its discussions on the issue.

The First Global Summit against Cervical Cancer in Paris on 22 March 2007, which was paid for by Merck's co-marketing partner in the EU, Sanofi Pasteur MSD, did not elaborate on any caveats, says The Guardian. The French firm launched a Coalition against Cervical Cancer with a charter signed by 30 or more female celebrities, as well as politicians and doctors. The coalition is to lobby Europe's governments to introduce mass vaccination and has already met with the Austrian health minister.

The Guardian claimed that journalists were paid to attend the summit, adding that a group of freelance health journalists from the UK not only had their travel, meals and accommodation expenses reimbursed, but also their had their time paid for by Sanofi Pasteur MSD. The Guardian added that a PR company working for Sanofi offered its own journalists flights to Paris and transport to and from Charles de Gaulle airport.

Since the FDA's approval of Gardasil in the US in 2006, the vaccine has been in high demand, according to local media reports. Each of the three jabs are administered within a six-month period to females aged nine to 26 years. Costing USD 360 for the whole course, a mandatory vaccination programme could make Merck a lot of money.

Despite the marketing push, the efficacy of Gardasil has been questioned in a recent study published in the Journal of the American Medical Association (JAMA). The study found that among women aged 14 to 24, the rate of all 37 types of sexually transmitted human papilloma virus (HPV) combined was 33.8 per cent, which was much lower than the 50 per cent figure cited by Merck.

The rates for HPV 16 and 18, which are the two viral types responsible for 70 per cent of all cervical cancers, are much lower - only 1.5 and 0.8 per cent, respectively.Also, in the February edition of the American Cancer Association Guidelines, it was reported that most HPV infections, even cancer-forming ones, disappear without treatment. Approximately 75 per cent of infections in adults and 90 per cent of those in adolescents resolve spontaneously.

According to US media reports, Merck's drug trials followed women who received Gardasil for an average of less than three years, so how long the immunity lasts or the long-term risks associated with it remains unknown. Children vaccinated in middle school could potentially lose their immunity by the time they were seniors in high school.

Even though the controversy continues, Gardasil could help Merck out of its financial crisis regarding the Vioxx recall and lawsuits over heart attacks caused by the drug. Also, sales of its cholesterol blockbuster drug Zocor (simvastatin) have been declining since its patent failed in 2006. Wall street analysts say that Gardasil could be a potential blockbuster for Merck, with sales surpassing USD 1bn a year by 2010, which is very high for a vaccine.

27th March 2007

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